Novo uses a PRV to submit oral semaglutide to FDA
- Diabetes specialist Novo Nordisk has submitted two New Drug Applications for its oral formulation of semaglutide for approval in the U.S., for glycemic control and for cardiovascular risk reduction, in adults with Type 2 diabetes.
- The oral semaglutide submission is based on results from 10 PIONEER clinical trials involving 9,543 adults with Type 2 diabetes. These showed greater blood glucose reductions for oral semaglutide compared with Januvia, Jardiance, Victoza or placebo, as well as greater weight reductions than most comparators.
- The Danish big pharma has also submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration for once-weekly injectable semaglutide (known as Ozempic in its injected form) for cardiovascular risk reduction in Type 2 diabetes.
Novo picked up a priority review voucher last year from an undisclosed source for its diabetes care and obesity development portfolio.
It's not clear how much the company paid for the voucher, but it intimated back in its fourth quarter earnings call that it would be used to speed up the review of its oral semaglutide, a once-daily GLP-1 analog.
Novo is using the voucher for the glycemic control indication. This will mean an anticipated review time of six months from submission, and shows that the company puts a lot of stock in the drug's potential on the market. The cardiovascular risk reduction indication for both the oral and injectable formulations will be reviewed in standard FDA timelines, so around 10 months.
Oral semaglutide could fill a niche for Type 2 diabetics, particularly those who struggle with the idea of injecting themselves.
"Achieving glycemic control and managing cardiovascular risk remains a challenge for many adults living with type 2 diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
It could also be a major competitor against other GLP-1 agonists, particularly Eli Lilly's once-weekly Trulicity (dulaglutide). A Cowen healthcare conference topical panel wrap-up from Monday described both injectable Ozempic and oral semaglutide as "strong competitors or class leaders", calling Ozempic "best-in-class."
The potential downside for oral semaglutide is that it needs to be taken 30 minutes before a meal, but for those with an aversion to needles, this may be a small price to pay.
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